Manager Global Regulatory Affairs
4 days ago
Slough
Regulatory Affairs Manager – International & Emerging Markets Blackfield Associates is proud to be partnered exclusively with an international pharmaceutical organisation that is expanding its International & Emerging Markets Regulatory team. We are seeking an experienced Regulatory Affairs Manager to take ownership of regulatory activities across EMEA and emerging markets. This is a hands‑on role for a regulatory professional with proven experience taking approved dossiers and managing local submissions across emerging markets, including direct interaction with Health Authorities. Key Responsibilities: • Prepare and submit new Marketing Authorisation Applications (MAAs) supporting international countries within the Emerging markets region, • Support global expansion through the submission of registration dossiers for existing products, • Lead dossier remediation activities, including aligning legacy registrations with current regulatory requirements to enable geographic expansion, • Support lifecycle management of marketed products, including Variations, Renewals, and PSURs, • Liaise closely with local Regulatory Affairs affiliates on regulatory documentation, including labelling, variations, and new registrations, • Provide hands‑on support for country‑specific labelling requirements, • Track registrations using relevant regulatory databases and tracking systems, • Provide regulatory input to cross‑functional teams, including portfolio management, out‑licensing, and launch management, • Proactively contribute to the development and continuous improvement of the Regulatory Affairs function, supporting the successful commercialisation of products across international markets within EMEA Required Experience & Qualifications • Degree‑qualified in a Life Sciences discipline or related field, • Minimum 5 years’ experience supporting international regulatory markets, • Proven experience managing new MAAs, global expansion of existing products, and extensive lifecycle maintenance (essential), • Experience working closely with international Regulatory Affairs affiliates, • Strong ability to manage multiple priorities and deadlines simultaneously, • Able to work independently while contributing effectively within a collaborative team environment Additional Information • This is a permanent, full‑time position, • Based at the Slough affiliate office, with hybrid working required, • Sponsorship is not available – candidates must have full right to work in the UK, • Flexibility around working hours is required due to international territories